Laser device for intracranial illumination via oral or nasal foramina access

ABSTRACT

A system and method of illuminating tissue, particularly within the cranial cavity, through the mouth or nose. The system includes a light source and a power source for powering the light source. Optics are included for directing light from the light source towards the cranial cavity when the apparatus is inserted into a cavity of the head. Light from the light source and output from the optic provides cellular interaction treatment toward a specified area of the head region. Providing illumination where there are already holes in the skull results in more efficient coupling of light to the cells.

RELATED APPLICATIONS

This application is divisional application and claims the benefit of thefiling date under 37 CFR 178 of U.S. patent application Ser. No.12/009,405, entitled LASER DEVICE FOR INTRACRANIAL ILLUMINATION VIA ORALOR NASAL FORAMINA ACCESS filed Jan. 18, 2008, now U.S. Pat. No.9,180,308.

TECHNICAL FIELD

This invention relates generally to laser illumination devices and moreparticularly to laser devices used in medical treatments.

BACKGROUND OF THE INVENTION

Photobiomodulation is a new field of medicine where generally low powerlight or low power laser radiation is applied to tissue with the idea ofprompting a cellular response. Although the physical chemistry is notwell understood, some theories and empirical data indicate that thelight interacts with the cell mitochondria and stimulates the energyproduction of the cell. Once cells performing a certain function getenergized a physiological response is observed. There are many tens ofindications that have been the basis of photobiomodulationexperimentation and clinical studies ranging from local aesthesia todermatological disorders. Some of the areas that have been best studiedare increase of blood flow, reduction in inflammation and wound healing.It is known that certain light applied to the skin will cause anincrease in blood flow.

An ischemic stroke is caused by a blood clot in the brain limiting bloodflow thereto and causing oxygen deprivation. Brain cells die in astroke, therefore, immediate treatment is necessary to avoid or limitpermanent brain damage.

Studies are under way to use lasers to stimulate blood flow to the brainduring a stroke. These studies involve illuminating the scalp with ahigh power laser and shining light through the hair, skin, hairfollicles, and skull into the brain.

SUMMARY OF THE INVENTION

An advance is made over the prior art in accordance with the principlesof the present invention that is directed to a new approach for a systemand method of illuminating tissue, particularly within the cranialcavity, through the mouth or nose. There are previous ideas forattempting to provide illumination on the outside of the skull.Providing laser illumination in areas where there are already holes inthe skull results in more efficient coupling of light to the cells.Illuminating the intracranial cavity results in an increase incirculation, increase in lymphatic system, reduction in inflammation,and stimulation of cellular activity. The invention will be used fortreatment of headaches, to lessen the effects of stroke if treatedduring a stroke, and acute trauma.

One embodiment of the invention sets forth an apparatus for illuminatingthe cranial cavity of a head. The apparatus comprises a light source anda power source for powering the light source. Optics are included fordirecting light from the light source towards the cranial cavity whenthe apparatus is inserted into a cavity of the head. Light from thelight source and output from the optic provides cellular interaction orphotobiomodulation treatment toward a specified area of the head region.

BRIEF DESCRIPTION OF THE DRAWING

The teachings of the present invention can be readily understood byconsidering the following detailed description in conjunction with theaccompanying drawings, in which:

FIG. 1 shows one exemplary embodiment of a laser illumination device inaccordance with one aspect of the present invention;

FIG. 2 shows one embodiment of a laser illumination device as used inconnection with the methodology of the present invention;

FIG. 3 shows another exemplary embodiment of a laser illumination devicein accordance with the present invention;

FIG. 4 shows an exemplary embodiment of a laser illumination devicesuitable forinsertion into the nasal cavity;

FIG. 5 shows a block diagram of a laser illumination device inaccordance with the principles of the present invention:

FIG. 6 shows a bi-lobal energy distribution from the output of laserilluminationdevice in accordance with one aspect of the presentinvention; and

FIG. 7 is a cross-section of the skull illustrating various foramina;and

FIG. 8 shows another exemplary embodiment of a laser illumination devicein accordance with the present invention.

DETAILED DESCRIPTION

Exemplary embodiments of the invention will now be described whilereferring to the figures, several of which may be simultaneouslyreferred to during the course of the following description.

Ischemic stroke is a traumatic but common event that afflicts over ahalf million people each year in the United States alone. A strokeoccurs when the blood supply to the brain has been blocked. This mostcommonly occurs when a clot finds its way to the brain. In most strokes,little harm occurs to the patient at the exact time that the firstsymptoms appear. Within hours of the first symptoms, however, which insome cases are not even severe enough to warrant a 911 call or a trip tothe hospital, permanent damage can occur.

Given the narrow therapeutic window before the effects of stroke canbecome more severe, timely diagnosis and treatment of ischemic strokeare paramount. Currently, anticoagulants and other drugs are the mostwell known and effective method used to treat strokes. Early applicationof photobiomodulation treatment for stroke and other ailments asdiscussed herein will not replace drugs, but may substantially open thetherapeutic window to allow for effective treatment with the drugs.

According to the American Stroke association, the chain of survival forstroke is as follows:

-   -   Detection—Recognition of stroke signs and symptoms;    -   Dispatch—Call 9-1-1 and priority EMS dispatch;    -   Delivery—Prompt transport and prehospital notification to        hospital;    -   Door—Immediate ED triage;    -   Data—ED evaluation, prompt laboratory studies, and CT imaging;    -   Decision—Diagnosis and decision about appropriate therapy; and    -   Drug—Administration of appropriate drugs or other interventions.        The photobiomodulation treatment described herein would ideally        be administered at the first sign of stroke symptoms by EMS or        directly administered by the patient or another person. Due to        the importance of timely treatment for stroke patients and the        fact that there are no known side effects to the presently        described photobiomodulation treatment, administering treatment        in the field before or during patient transportation to the        medical facility would appear to be a prudent approach.

As discussed, ischemic stroke occurs when blood supply leading to thebrain is blocked by a blood clot. Brain cells that are not able to getenough blood and oxygen die, which may result in a disabling injury ordeath. The present invention discloses a system and method forilluminating tissue, particularly within the cranial cavity, that mayprovide an increase in circulation and stimulation of cellular activityto aid in the treatment for stroke. As described herein, theillumination treatment of the present invention takes place through themouth or nose. Prior art techniques for illuminating the brain apply anillumination source through the outside of the skull. Such techniquesmay be hampered, however, because the skull, skin and hair absorb,reflect and scatter light. As will be described, providing laserillumination in areas where there are already voids in the skull resultsin a more efficient coupling of light to the cells that need to betreated.

Photobiomodulation applications have taken place in the prior art usinglow power light or laser radiation. The power levels required for suchapplications to have an effect on the tissue can be quite low. There isevidence that suggests power levels from 5 mW to 20 W can be effectivefor various cellular interactions.

Diode lasers are tiny lasers that efficiently convert electrical energyto electromagnetic radiation. Semiconductor lasers (diode lasers) aretypically made from epitaxial layers of AlGaAs or aluminum-freematerials grown on a GaAs substrate. The materials are then processedand packaged such that excess heat can be efficiently removed. Given thecurrent state of diode laser technology, single emitter 100-200 micronwide and 1-2 mm long near infrared diode lasers diode lasers arecommercially available with power levels up to about 5 W. Thus, thepower levels of laser diodes are within the effective range for use inphotobiomodulation treatments. If necessary, multiple single emitterscan be coupled on a bar or as single chips in order to provideadditional power.

The present invention relates to a system and method for applyingradiation from a semiconductor diode laser or other light source to anarea below the skull that is accessed via the nasal cavity or mouth. Inone embodiment of the invention, light from the light source istransmitted via a fiber optic or light coupler to below the skull andinto an area of the brain. In this way, the light source may be locatedremote from the light output, if desired. Examples of other lightsources that may also be utilized in connection with the inventioninclude lamps, flashbulbs and LEDs.

Referring to FIG. 1, one exemplary embodiment of an internal laserillumination device 10 in accordance with the present invention isshown. As shown, the illumination device 10 includes two main portions:a main housing 12 which includes the laser diode, heat sink and powersource among other things and a guide plate 14 which is insertable intothe mouth and includes the laser output and any suitable optics. Themain housing 12 and guide plate 14 are coupled to one another via arigid or semi-rigid longitudinal member 16 that includes a fiber opticcable 18, e.g., a multi-mode fiber optic cable, positioned therein.Thus, one embodiment of the device resembles a tongue depressorinstrument or even a lollipop that is graspable by way of the housingsection. Although the guide plate 14 is shown as having an essentiallyflat shape, it would be understood that this portion of the device maytake on a variety of different shapes, e.g., semi-spherical and othershapes having one flat side, that would also be suitable forphotobiomodulation applications. The fiber optic cable 18 enables thelaser output 20 from the laser diode to be directed to and output fromthe guide plate in a desired manner. Also by coupling the main housingand guide plate together by way of a semi-rigid even flexible member 16,a patient or caregiver using the device will be able to hold andmanipulate the device in a manner comfortable to the patient.

In one embodiment of the invention, the laser source is configured likea conventional laser pointer. That is, a power source and laser diodemay be located in the housing 12 having an activation mechanism 22, suchas a switch or turn activator, which when placed in the activationposition energizes the laser diode via the power source. In the shownembodiment, the power source is a battery. Assuming a 5 W laser diode, a1.5V, 7 A battery would be suitable for use as a power source for usewith the present invention. Batteries with sufficient current capabilityfor operation of the above-type laser diodes over a one half hour timeperiod, for example, are commercially available. A person skilled in theart would realize that different size batteries may be utilizeddepending on the power requirements of the diode and the specificoperating parameters. Providing power to the device of the presentinvention via battery enables the device to be portable, so that thedevice may be easily transported with an individual during use. It wouldbe understood, however, that the device of the present invention mayalternatively be AC powered via cord 24 and conventional wall outlet, ormay be operable in conjunction with a rechargeable battery, so that thedevice may be chargeable for later operation over a given period oftime. In the case of a rechargeable unit, the illumination device of thepresent invention would be insertable into a separate charging base forcharging purposes or else be adapted to accept the input of a chargingunit in a fashion similar to that of a cell phone charger. One exampleof a suitable design for rechargeable equipment incorporating laserdiodes is given in U.S. Pat. No. 7,118,563 to Weckwerth et al., thecontents of which are incorporated by reference herein.

In the shown embodiment of the device, the guide plate 14 which isinsertable into the mouth, and which includes the laser output 20 partof the device, is flat on one side 26 and the laser output of the deviceis included on an opposite side 28 (see FIG. 2). The laser output sideof the device, when inserted into the oral cavity and turned on, directsthe output laser light 30 upwards in a general direction towards theroof of the mouth. Instructions on the device indicate the direction oforientation for the laser output, for example, one side of device mayhave indicia thereon, at the guide plate, for example, indicating “thisside up” and/or “this side on tongue”. The device also includes anoptical device such as a lens 32 that couples to the end of the fiberoptic cable and generally serves to direct or scatter the light sourceand generate a desired spot size at a specific location, for example atthe back of the mouth. The optical component also serves to encapsulateand offer protection to the tip of the fiber optic. In the case ofinstitutional models of the present invention that will be reused, theguideplate will be adapted to accept a disposable encapsulant, e.g., atransparent cover, to enable easy re-use. In either case, appropriateportions of the device will be sealed in order to protect the devicefrom moisture or other contaminants and so that a re-usable device maybe efficiently cleaned.

Referring to FIG. 3, the device would also have a guard or stop 40 toshow generally how far to insert the device into one's mouth. As shown,the stop 40 is illustrated as a transverse cross member that is attachedat a location along the longitudinal member. Since the stop has widerdimensions than a person's mouth, once the stop is in contact with theouter portion of a patient's mouth, this will be an indication that thedevice should not be inserted any farther into the mouth. At the sametime, when the stop member of the device is positioned at or near theoutside of the patient's mouth, this will indicate favorable placementof the device in order to direct radiation toward the roof anindividual's mouth. It would be understood, that the stop 40 may take onvarious different forms as long as the stop acts to assist with properplacement in the oral cavity. For instance, the stop could be abiteplate or mouthpiece that is insertable into a patient's mouth. Inaddition, the stop could be made to be adjustable depending on theinternal size of a patient's mouth such that optimal orientation withinthe mouth is always achieved. For example, the adjustable insertiondepth may be gauged by the head size or other related metric of apatient or may be based on the general feel within the mouth—e.g., so asnot to initiate a gag reflex. In order to make the stop adjustable, thelongitudinal member may have a number of preset positions into which thestop may be set in place thereon, such that the stop is able to be movedalong the longitudinal member and be clamped or affixed into at one ofthe preset positions. Other known methods for maneuvering and holdingthe stop in place along the longitudinal member may also be utilized.

Still referring to FIG. 3, in one exemplary embodiment of the invention,the device of the present invention may also be equipped with a safetyinterlock to ensure that appropriate portions of the device arecompletely inside the mouth before the laser can be turned on. A safetyinterlock feature in accordance with the present invention can beachieved in a variety of manners, as will be described. In oneembodiment, a biteplate 70 having a mechanical switch within isprovided. A user of the laser illumination device is required to bitedown on one or more areas of the biteplate 42 into which dental contactwould take place in order to activate (or close) the included switch.Once the switch is activated, indicating that the laser is encompassedwithin the user's mouth, the laser is enabled.

In another embodiment, the safety interlock is an ohmic interlock 44.Here, a benign voltage is applied to one of two electrodes 46 on thedevice. The electrodes 46 can be placed, for example, on the bottom 26of the (lollipop) guide plate 14 or on a part of the device that isoutside of the mouth, such as the stop, where portions of the stop maybe curved in order to make wrap around contact with a user's face. Whenboth of the electrodes are in contact with a surface of the skin ormouth, an electrical circuit is completed, since resistance of the bodyis within a certain known range. The completed circuit enables the laserto be safely tuned on within the patient's mouth.

In another embodiment, a photonic sensor may be utilized, such that iflight was present at wavelengths shorter than 600 nm, for example,visible light ranges, then the laser would not turn on. Accordingly, ifthe patient's mouth was open or opens, then the laser will in turndeactivate.

Another option is the use of a bio-sensor, which senses the heartbeat ofa patient, through contact with the inside of the patient's mouth, forexample, in order for the laser to be activateable. One or more of theabove described safety interlocks may be utilized in order to ensuresafe operation of the present invention laser illumination device. AnLED or other visual indicator may also be included on the outside of thedevice such that the patient or any attending medical professional canreadily determine that the laser light source is in operation. Anaudible indicator may also be utilized instead of or in addition to thevisual indicator to demonstrate operation.

Referring to FIG. 2, there is shown a depiction of the illuminationdevice 10 as it is inserted into the oral cavity of a patient. As can beseen, light or radiation 30 from the device is directed upwards towardthe roof of one's mouth when the device is energized. Since there are anumber of voids within the bone structure on the inside of the humanhead, as the light is directed upwards an efficient coupling of light orlaser radiation is able to be achieved into the brain area. Morespecifically, other known methods of applying laser radiation throughthe outside of the skull encounter difficulties in penetrating the skullas well as reflections from the hair and skin. Since the ability toprovide quick and meaningful treatment to a stroke victim can mean thedifference between lasting injuries and less severe complications,having a mechanism for the easy and effective delivery of laser lightfor photobiomodulation may offer significant advantages for this type oftreatment.

As discussed above, a fiber pigtailed laser diode, although notnecessary, is a viable approach to illuminate the cranium through theforamina. The fiber pigtailed approach offers a few advantages. Firstly,it separates the electrical supply from the tissue. This would not beentirely necessary as the voltage will be relatively low on the diodeanyway, however, there may be some safety and regulatory issues thatmake the approach particularly advantageous. Moreover, if it is laterdetermined that there is more of a clinical advantage to input the lightthrough the nasal cavity, then the fiber optic probe will offer asignificant advantage due to the relatively small diameter andflexibility of the fiber optic cable. Also, depending upon the power ofthe diode, it may be quite awkward to insert a diode and heat sink intoeither the nose or mouth. With respect to nasal insertion, this wouldalso mandate that the diode laser be on the lower end of the power rangediscussed, since the power density at the output of the fiber will bemuch higher than if the laser is allowed to diverge to a nominal oneinch spot, for instance, on the roof of the mouth, as in the case oforal insertion. From a very general standpoint, except for the reasonsmentioned above relating to the fiber coupling, there is no therapeuticneed for high brightness.

Referring to FIG. 4, there is shown another exemplary embodiment of alaser illumination device 50 in accordance with the present invention.The shown embodiment is especially adapted for insertion into the nasalcavity. The basic structure of the device is similar to the device usedfor insertion into the mouth except that the guide plate 52 is adaptedfor insertion into the nose as opposed to the mouth. In the shownembodiment, the guide plate 52 is or is adapted for use with aside-firing fiber 54. The side-firing fiber 54 differs from aconventional fiber optic in that rather than light being transmitted outof the end of the fiber, the light is output from the sides of thefiber, where the output may be made to be up to 360 degrees around orany interval or intervals less than 360 degrees. Here, the guide plate,which may be some form of encapsulant, is generally cylindrical in shapeand serves to orient the output of the fiber optic in a rearward andupward direction toward the brain as opposed to the more upwardorientation of the mouth insertable version. Other mechanisms foroutputting and orienting light transmitted from a conventional orside-firing laser may also be utilized.

Referring to FIG. 5, there is shown a block diagram of one embodiment ofa laser illumination device 60 in accordance with the present invention.As shown, the main housing of the device includes a laser diode 62 andheatsink 64. A power source 66, either a battery or AC power source, asdiscussed, powers the laser diode and is activated by a switch. Thelaser diode is controlled by a logic controller 68 which controls theoutput of the laser diode to be either continuous or to produce pulsesof a specific duration, as would be understood. As mentioned, the logiccontroller will also be capable of producing a pulsed output, where apulsed output is recognized as being a preferable delivery mechanism forstimulation of cells for certain treatments. Lasers are commerciallyavailable that deliver 7 W of average power, for example, Biolase modelezlase (http://www.biolase.com/ezlase/) is a commercial laser delivering7 W of average power at 810, 940, 980 nm. A fiber optic 70 similar tothat of the Ezlase™ couples to the output of the laser. A mechanicalhousing 72 for the fiber, shaped as described herein, for example, likea lollipop, for orienting the fiber appropriately on the tongue couplesto or includes parts of the fiber optic 70 therein. An optic (or lens)is coupled after the fiber in the disc part (guide plate) of thelollipop to project the light in the appropriate direction and to theappropriate spot size on the back of the roof of the mouth. In oneexemplary embodiment of the invention a spot size of approximately oneinch or greater in diameter is projected onto the roof a mouth. The spotsize would be variable based on lens type and depending on the intendedapplication of the treatment. In addition, the wavelength of the laserwould be in the range of 500-1100 nm, as lasers with wavelengths between630-1000 nm have good tissue transmission, thus, those wavelengths areconsidered to be generally acceptable for the instant application.

The laser spot could be a round, oval, bi-lobal, or other shaped imageon the back of the roof of the mouth. Referring to FIG. 6 in combinationwith FIG. 2, it can be seen that in the center of the back of the mouth,the bottom of the skull will block radiation from entering the cranium.FIG. 6 shows a high level top cross-section of the human inferior skullwhich illustrates the locations of the various foramina 80, 82, 84 ofthe skull. It may be advantageous to have the energy distribution thatis delivered to the roof of the mount be bi-lobal, multi-lobal orotherwise patterned to thereby better overlap with the foramina of theskull. See FIG. 7 which illustrates a bi-lobal energy distribution 90which may be achieved with a dual or split fiber output or similarfunctioning lens. With this approach the light to the brain may beoptimized without excessive heating to the mouth.

As discussed, the present invention may be used to deliverphotobiomodulation treatment for a number of different indicationsincluding, but not limited to: acute aschemic stroke, memoryimprovement, improving the thought process, treatment for diseases ofthe brain, acute trauma to the head, excitation of glands in the head,photodynamic therapy, etc. Illuminating the intracranial cavity resultsin an increase in circulation, increase in lymphatic system, reductionin inflammation, and stimulation of cellular activity. Accordingly, theinvention may be used for treatment of headaches, to lessen the effectsof stroke if treated during a stroke, and acute trauma.

The intracranial illumination device of the present invention can be putinto operation once it is determined that a condition exists that couldbenefit from photobiomodulation treatment to the head or brain area, forexample, any of the indications described above, such as aschemicstroke, head trauma, etc. Operation of the device is relatively simple,where the device is turned on and inserted into the oral or nasal cavityto a prescribed depth. The appropriate depth may be indicated by contactwith the stop of the device at the exterior of a patient's oral or nasalcavity. Or the appropriate depth of insertion may be obtained by feelwithin the patient's mouth or nose—(where general discomfort wouldindicate over-insertion). The device can remain on and in applicationmode for a prescribed period of time. As described previously, a safetyinterlock feature may also be included in the device, whereinappropriate measures would need to be taken by the user or care giverbefore the illumination device will activate. The inventor is unaware,however, of any potential side effects for treatment of tens of minutesat power levels of single digit wattage using the present invention.

The foregoing description merely illustrates the principles of theinvention. It will thus be appreciated that those skilled in the artwill be able to devise various arrangements, which, although notexplicitly described or shown herein, embody the principles of theinvention, and are included within its spirit and scope. Furthermore,all examples and conditional language recited are principally intendedexpressly to be only for instructive purposes to aid the reader inunderstanding the principles of the invention and the conceptscontributed by the inventor to furthering the art, and are to beconstrued as being without limitation to such specifically recitedexamples and conditions. Moreover, all statements herein recitingprinciples, aspects, and embodiments of the invention, as well asspecific examples thereof, are intended to encompass both structural andfunctional equivalents thereof. Additionally, it is intended that suchequivalents include both currently known equivalents as well asequivalents developed in the future, i.e., any elements developed thatperform the same function, regardless of structure. Many othermodifications and applications of the principles of the invention willbe apparent to those skilled in the art and are contemplated by theteachings herein. Accordingly, the scope of the invention is limitedonly by the claims.

What is claimed is:
 1. A method for illuminating the cranial cavity of ahead, said method comprising: inserting a light guide into a cavity ofthe head being the oral cavity, said light guide providing light from alight source in a range of between 500-1100 nm; and directing light fromsaid light source towards said cranial cavity, wherein light from saidlight source and output from said light guide providesphotobiomodulation treatment toward a specified area of the head regionfurther including optics for directing light from said laser lightsource and providing a light beam with a light pattern having a spotsize and spot shape toward the back of said oral cavity, said light beamaligning with at least the lacerium foramina of the skull and providinglight through said at least lacerium foramina into said cranial cavitysaid light source configured to provide light of sufficient power leveland wavelength in order to penetrate tissue within the head region andreach said cranial cavity through said at least lacerium foramina. 2.The method of claim 1, wherein said light source is selected from thegroup consisting of laser diode and laser.
 3. The method of claim 2,wherein said light source produces an average output power in the rangeof 150 mW-20 W.
 4. The method of claim 1, wherein the light source is alaser diode having an output power level between 150 mW-20 W.
 5. Themethod of claim 1, wherein the light source is operable in connectionwith a safety interlock mechanism for preventing output of the lightsource when the apparatus is outside of said cavity.
 6. The method ofclaim 1, wherein the light source is a laser diode.
 7. The method ofclaim 1, wherein the light source is a red or NIR laser from 630-1100nm.
 8. The method of claim 1, wherein light from the light source isused for treatment of indications selected from the group consisting of:stroke, memory improvement, improving the thought process, treatment fordiseases of the brain, acute trauma to the head, illumination of glandsin the head, photodynamic therapy and stimulation of the lymphaticsystem.
 9. The method of claim 1, wherein optics create a pattern thatis directed through foramina of the skull.
 10. The method of claim 9,wherein the light guide is for insertion into the oral cavity, whereinoptics are adapted to output a multi-lobal energy distribution, whereinat least two output lobes are directed towards oral foramina of theskull.
 11. The method of claim 1, further including a guide plateadapted for contact with the tongue for accepting and orienting thelight output from said optics toward a given region of the head.
 12. Themethod of claim 11, wherein said guide plate has at least one generallyflat planar side.
 13. A method for providing photobiomodulationtreatment by application of a laser light source to the cranial cavity,said method comprising: providing a laser light source, a power modulefor powering said light source and an optical transmission mediumcoupled to said light source; inserting a guide plate into a mouth of ahuman patient, said guideplate coupling with said optical transmissionmedium, said guide plate having a generally planar bottom surface thatrests substantially flat on a tongue of said patient, said guide plateadapted to, when positioned on the tongue, orient a light beam producedfrom said light source and traveling through said optical transmissionmedium in a spot size and output pattern that irradiates the roof of themouth so as to direct and align a portion of said light beam with atleast one foramina of the skull, said guide plate further includingoptics on an opposite side of said generally planar bottom surface foroutputting said light beam, light from said light beam being directedthrough said at least one foramina of the skull such that light fromsaid laser light source penetrates tissue within said mouth to travel ina desired direction within the cranial cavity, said laser light sourceproviding light of sufficient power and wavelength in order to penetratesaid tissue within said mouth and enter said cranial cavity of saidskull through said at least one foramina to thereby provide saidphotobiomodulation treatment.
 14. The method of claim 13, wherein lightfrom the light source is used for treatment of indications selected fromthe group consisting of: stroke, memory improvement, improving thethought process, treatment for diseases of the brain, acute trauma tothe head, illumination of glands in the head, photodynamic therapy andstimulation of the lymphatic system.
 15. The method of claim 13, whereinsaid light source produces an average output power in the range of 150mW-20 W.
 16. The method of claim 13, wherein said light source producesan average output power in the range of 5 mW-20 W and a given spot size.17. A method for providing photobiomodulation treatment by applicationof a laser light source to the cranial cavity, said method comprising:providing a laser light source, a power module for powering said lightsource and an optical transmission medium coupled to said light source;inserting a guide plate into a mouth of a patient, said guideplatecoupling with said optical transmission medium, said guide plate actingto orient light produced from said light source and traveling throughsaid optical transmission medium in a desired direction within thecranial cavity when the guide plate is placed into the mouth of saidpatient; said guide plate configured for insertion into a mouth of ahuman patient for coupling with said optical transmission medium, saidguide plate having a generally planar bottom surface that restssubstantially flat on a tongue of said human patient, said guide platefurther including optics on an opposite side of said generally planarbottom surface and a lens configured to orient a light beam producedfrom said light source and traveling through said optical transmissionmedium toward the back of said mouth in a spot size and output patternthat irradiates said back of said mouth so as to direct and align saidlight beam with at least one foramina of the skull, light from saidlight beam being directed through said at least one foramina of theskull such that light from said laser light source penetrates tissuewithin said mouth to travel in a direction based on orientation of saidlens within the cranial cavity, said laser light source providing lightof sufficient power and wavelength in order to penetrate said tissuewithin said mouth and enter said cranial cavity of said skull throughsaid at least one foramina to thereby provide said photobiomodulationtreatment wherein said lens is configured to output a multi-lobal energydistribution, wherein at least two output lobes are directed throughoral foramina of the skull and wherein the light source is a laser diodehaving a wavelength in the range of 500-1100 nm.
 18. The method of claim17, wherein light from the light source is used for treatment ofindications selected from the group consisting of: stroke, memoryimprovement, improving the thought process, treatment for diseases ofthe brain, acute trauma to the head, illumination of glands in the head,photodynamic therapy and stimulation of the lymphatic system.
 19. Themethod of claim 17, wherein the light source is operable in connectionwith a safety interlock mechanism for preventing output of the lightsource when the apparatus is outside of the mouth.
 20. The method ofclaim 17, wherein said light source produces an average output power inthe range of 5 mW-20 W and a given spot size.